XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Andrew Yee, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01582295
First received: April 19, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means the FDA has not approved the drug for your type of cancer.

Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow or stop disease growth to bones and prevent cancer growth.

In this research study, we are looking to see how effective cabozantanib is in slowing or stopping disease growth to the bones as well as preventing your cancer from worsening. We are also looking for the highest dose of cabozantinib that can be given safely to patients who have multiple myeloma with bone disease.


Condition Intervention Phase
Multiple Myeloma
Drug: Cabozantinib
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Finding Pilot Study of Cabozantinib (XL184) Administered Orally as Monotherapy for the Treatment of Patients With Relapsed or Relapsed/Refractory Multiple Myeloma With Bone Disease

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Safety of Cabozantinib [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the safety of cabozantinib in patients with multiple myeloma with bone disease


Secondary Outcome Measures:
  • Changes in Biochemical Markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Changes in biochemical markers of bone turnover, including serum bone specific alkaline phosphatase, osteocalcin, sclerostin, P1nP (procollagen type 1N propeptide) and urine N-telopeptide before treatment and end of cycle 2

  • Effect of Cabozantinib on Bone Disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To evaluate the effect of cabozantinib on bone disease as assessed by post-treatment changes on whole body FDG-PET/CT scan before treatment and end of cycle 2

  • Objective Response per IMWG [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Objective response according to the International Myeloma Working Group Uniform Response Criteria (IMWG)

  • Pain Assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Pain will be assessed using the Pain Assessment Tool included in the appendix. The questionnaire will be administered at screening, day 1 of each cycle and end of treatment


Estimated Enrollment: 22
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Cabozantinib ( XL 184)
Drug: Cabozantinib
Starting dose 40 mg daily
Other Name: XL 184

Detailed Description:

Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.

The study drug, cabozantinib, comes in the form of tablets which you will take by mouth. You will take your dose of cabozantinib once a day during each 28 day cycle.

Detailed instructions on how to take the study drug and which foods and drinks you will be prohibited from taking during the research study can be found in your study drug diary.

During Cycle 1, you will come into the clinic weekly (Day 1, 8, 15 and 22). For all other cycles, you will come into the clinic on Day 1 and 15.

A visit will be scheduled 30 days after you have finished or stopped taking the study drug so your doctor will be able to check your well being.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed/Refractory Multiple Myeloma
  • Skeletal lesions suggestive of bone involvement
  • Must have received at least 2 lines of prior systemic therapy for the treatment of multiple myeloma
  • Must have received prior treatment with a proteasome inhibitor
  • Agree to use medically accepted barrier method of contraception
  • Not a candidate for ASCT, has declined the option or has relapsed after prior ASCT

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Has received radiotherapy to thoracic cavity or GI tract (within 3 months of first dose of study drug), bone or brain metastasis (within 14 days of first dose) or any other site (within 28 days)
  • Has received any other investigational agent within 28 days
  • Primary brain tumor
  • Uncontrolled, significant intercurrent or recent illness
  • Cardiovascular disorder(s)
  • Gastrointestinal disorder(s)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582295

Contacts
Contact: Andrew Yee, MD 617724-4000 ayee1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Yee, MD    617-724-4000    ayee1@partners.org   
Principal Investigator: Andrew Yee, MD         
Sub-Investigator: Noopur Raje, MD         
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, MD    617-632-4218    JacobP_Laubach@dfci.harvard.edu   
Principal Investigator: Jacob Laubach, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Andrew Yee, MD Massachusetts General Hospital, Boston
  More Information

No publications provided

Responsible Party: Andrew Yee, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01582295     History of Changes
Other Study ID Numbers: 12-005
Study First Received: April 19, 2012
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Bone disease

Additional relevant MeSH terms:
Bone Diseases
Multiple Myeloma
Neoplasms, Plasma Cell
Musculoskeletal Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014